The present invention generally relates to angioscopy catheters and procedures. More particularly, the invention relates to a double-lumen catheter which is particularly intended for angioscopic uses. During use, the two-channel or double-lumen portion of the catheter is inserted into a patient. One channel accommodates a guidewire, while the other channel accommodates an optic fiber bundle, in particular a fiber bundle of an endoscope. The guidewire and the optic fiber bundle are capable of being inserted into and pushed through their respective channels. The guidewire and the fiber bundle can be fed in and manipulated separately of one another by way of single-lumen portions of the catheter proximal of the double-lumen portion of the catheter. In a preferred aspect of the invention, the transition from the single-channel catheter portions to an intermediate fork piece and from the intermediate fork piece to the two-channel portion of the catheter is uniform, there being no internally protruding edges which could make difficult the introduction of the guidewire and/or the optic fiber bundle in either direction, that is either into the distal end (double-lumen portion) or into the proximal end (either single-lumen portion).
During angioplasty treatments and the like, procedures are known and used whereby a lesion is located by means of x-ray based procedures which utilize radiopaque dyes and instruments having radiopaque areas which provide an image to assist the surgeon in diagnosing and treating diseased areas by transluminal procedures. While these approaches have met with reasonable success, it is believed that improvements in diagnosis and treatment can be attained by being able to actually view the lesion or other diseased area, rather than be limited to only images created by radiopaque materials. Actual viewing, such as through an optic fiber bundle, provides a three-dimensional view allowing an assessment of characteristics of the diseased area that cannot be attained by way of radiopaque images. It is also generally desirable to be able to view the lesion or other treated area after treatment, as well as before treatment. A procedure such as angioscopy allows for a direct look at a stenosis with the objective of being able to see the kind of material the stenosis is comprised of.
As is the case for any inner luminal procedure, minimizing the number of insertions and withdrawals of implements within body vessels is an objective to be sought. Also, difficulties can arise in attempting to properly position optic fiber bundles within vessels, particularly steering movement of the distal tip of optic fiber bundles to direct the viewing path as desired. Another difficulty which can be associated with fiber optic bundles when used within body passageways such as blood vessels is the accumulation of vision-obscuring materials such as blood and the like along the viewing pathway of the optic fiber bundle.
It has been found that the double-lumen angioscopy catheter and method in accordance with the present invention achieve the advantages of being able to manipulate an optic fiber bundle so that it is properly guided to the desired location for actually viewing a lesion or other diseased area prior to and/or after treatment of the diseased area. Included are means for flushing vision-obscuring materials such as blood and the like away from the field of view of the optic fiber bundle. At the same time, the invention requires only a single insertion of a guidewire to and beyond the diseased area, which guidewire can remain substantially in place throughout the duration of the procedure.
In summary, the present invention achieves these objectives and provides advantageous results along these lines by providing and using a double-lumen angioscopy catheter having a length of double-channel tubing positioned distally of a fork member which thereby connects the double-channel tubing to lengths of single-channel tubing whereby the double-channel tubing can be positioned within the body while the lengths of single-channel tubing are accessible from outside of the body. By this arrangement, access is provided in the form of continuous, separate passageways which are preferably smooth-walled from the distal tip of the double-channel tubing to a proximal portion of each length of single-channel tubing. One of these continuous passageways accommodates a guidewire, while the other accommodates an optical fiber bundle. The procedure for using the device includes inserting the guidewire at a location to the diseased area, such as distally beyond a lesion and substantially maintaining the guidewire in place at this location within the body. The double-lumen angioscopy catheter is then passed over and slidably guided by the guidewire whenever viewing of the diseased area is desired. Guidewire arrangements with respect to the optical fiber bundle facilitate steering at the distal tip of the optic fiber bundle. Preferably, flushing means are provided whereby this viewing operation can be accompanied by flushing of blood and the like away from the viewing pathway of the fiber optic bundle. Furthermore, the guidewire is usable, with the angioscopic device having been removed, for guiding an angioplasty catheter to the location for treatment.
It is a general object of the present invention to provide an improved angioscopy catheter and method of its use.
Another object of the present invention is to provide an improved angioscopic catheter having a double-lumen structure for accommodating both a guidewire and an elongated optic member generally longitudinally adjacent to one another.
Another object of this invention is to provide an improved procedure for treating disease transluminally which permits an actual optic fiber viewing of the diseased area without requiring more than one insertion of a guidewire to the diseased area being treated.
Another object of this invention is a double-lumen angioscopy catheter and method for the production of a fork portion thereof which provides a uniform and smooth transition from single-channel parts to a two-channel catheter portion, without forming internally protruding edges along the transition area.
Another object of the present invention is to provide an assembly of a double-lumen angioscopy catheter having a guidewire with a curved portion at or near its distal or leading end whereby rotating the guidewire about its longitudinal axis orients the catheter, particularly the optic fiber bundle thereof in a desired direction.
Another object of the present invention is to provide means for the person administering treatment to see that the extremity of the double-lumen catheter is about to extend beyond the distal end of its guiding catheter.
These and other objects, features and advantages of this invention will be clearly understood through a consideration of the following detailed description.